CBER, CDER, CDRH Recordkeeping Requirements

Export Notification and Recordkeeping Requirements

OMB: 0910-0482

IC ID: 213327

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Information Collection (IC) Details

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CBER, CDER, CDRH Recordkeeping Requirements
No Modified
21 CFR 1.101(b)(c)(e)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety


181 0
Private Sector Businesses or other for-profits
   90 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 746 0 0 -214 0 960
Annual IC Time Burden (Hours) 16,412 0 0 -4,708 0 21,120
Annual IC Cost Burden (Dollars) 0 0 0 -96,000 0 96,000

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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